Gynecologic oncology | 2019
Non-pegylated liposomal doxorubicin (NPLD, Myocet®)\u202f+\u202fcarboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial.
Abstract
BACKGROUND\nCarboplatin and pegylated liposomal doxorubicin combination is a standard regimen in platinum-sensitive recurrent ovarian cancer patients. The pegylated liposomal doxorubicin shortage from 2011 to 2013 urged assessment of the efficacy and tolerance of non-pegylated liposomal doxorubicin in combination with carboplatin.\n\n\nMETHODS\nMYCA was a multicenter 2-step phase Ib-II single arm trial meant to assess the safety and efficacy of carboplatin AUC 5\u202fmg/min.mL combined with non-pegylated liposomal (dose escalation from 40 to 50\u202fmg/m2 during phase Ib step; and 50\u202fmg/m2 during phase II step), every 4\u202fweeks in patients with platinum-sensitive relapse. The primary objective was disease control rate (DCR) at 12\u202fmonths.\n\n\nRESULTS\nFrom 2012 to 2014, 87 patients were enrolled. They were treated as second (78%) or third line (22%) treatment. Total of 67 patients (78%) completed 6\u202fcycles. G-CSF support was prescribed to 58% patients. The DCR at 12\u202fmonths was 30.0% (95% CI, 20.3-39.7); the median PFS was 10.0\u202fmonths (95% CI, 8.6-11.0). The median overall survival was 28.1\u202fmonths (95% CI, 22.3-32.5); and the objective response rate was 58% (95% CI, 47-68). Grade 3-4 neutropenia, anemia and thrombocytopenia were observed in 17%, 13% and 1%, respectively; febrile neutropenia in 6%. One patient who did not receive GCSF support died from febrile neutropenia.\n\n\nCONCLUSION\nNon-pegylated liposomal doxorubicin-carboplatin combination exhibits an acceptable safety profile, with GCSF prophylaxis. Acknowledging the lack of direct comparison, efficacy in terms of 12\u202fmonth DCR was comparable with standard treatments.